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FSD Pharma files Phase 2 clinical trial IND with the FDA for its lead candidate micro-PEA to treat coronavirus patients

The biotech said that the study is expected to be conducted at 25 to 30 hospitals in North America

FSD Pharma - FSD Pharma files Phase 2 clinical trial IND with the FDA for its lead candidate micro-PEA treat coronavirus patients
FSD Pharma is developing micro-PEA, or FSD-201 for its anti-inflammatory properties to avoid the cytokine storm associated with acute lung injury in hospitalized COVID-19 patients

FSD Pharma Inc (NASDAQ:HUGE) (CSE:HUGE.CN) (FRA:0K9A) announced on Monday that it has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for the use of its lead candidate FSD-201, or anti-inflammatory ultra-micronized-palmitoylethanolamide (PEA), to treat coronavirus (COVID-19) patients.

The company said that “severe COVID-19” is characterized by an “over-exuberant inflammatory response” that may lead to a cytokine storm and ultimately death. FSD Pharma is developing FSD-201 for its anti-inflammatory properties to avoid the cytokine storm associated with acute lung injury in hospitalized COVID-19 patients.

READ: FSD Pharma wins FDA nod to design Phase 2a clinical trial of its lead candidate micro-PEA to treat coronavirus patients

The trial will be a randomized, controlled, double-blind, US multicenter study at 25 to 30 sites, to assess the effectiveness and safety of FSD-201 dosed at 600 mg or 1,200 mg twice-daily, together with standard of care (SOC), versus SOC alone in hospitalized patients with documented COVID-19.

“The exploratory endpoint is cytokine clearance as measured by Enzyme Linked Immunosorbent Assay (ELISA),” the company said in a statement.

Separately, FSD said the company’s board has authorized the dispersion of an additional 369,255 class B subordinate voting shares to CEO Raza Bokhari and certain directors, officers, employees and consultants as share-based compensation.

Dr Bokhari received 805,802 Class B shares instead of cash compensation for his services as CEO. As a result, Dr Bokhari now owns around 8.5% of the issued and outstanding Class B shares. Dr Bokhari also continues to hold 33.3% of the group's outstanding class A multiple voting shares, and, in aggregate, he controls around 23% of the voting rights linked to FSD Shares.

The company noted that Dr Bokhari acquired the Class B Shares for “investment purposes" and has "no present intention" to sell the securities.

Contact the author Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive

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FSD Pharma aims to initiate a Phase 2 coronavirus treatment trial by end...

FSD Pharma Inc (NASDAQ:HUGE) (CSE:HUGE.CN) (FRA:0K9A) CEO Raza Bokhari tells Proactive the group has submitted an Investigational New Drug (IND) application to the FDA for the use of its lead candidate FSD-201, or anti-inflammatory ultra-micronized-palmitoylethanolamide (PEA), to treat...

1 week, 5 days ago

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